(158 days)
The EKOS PE Endovascular Device with CU 4.0 is indicated for the:
- Ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism.
- Infusion of solutions into the pulmonary arteries.
- Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
The EKOS PE Endovascular System consists of an EKOS PE Endovascular Device and CU4.0 (Control Unit 4.0 and Connector Interface Cables). The EKOS PE Endovascular Device consists of a single-use, disposable infusion catheter with removable ultrasound core. The infusion catheter contains multiple side holes distributed over the length of the treatment zone. The ultrasound core contains up to 20 ultrasound elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor catheter temperature. The Control System generates and controls the delivery of radiofrequency energy to the ultrasound core while monitoring and controlling the temperature of the treatment zone.
The provided text is related to a 510(k) premarket notification for a medical device called the EKOS PE Endovascular Device with Control Unit 4.0. This document describes the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence.
However, the information provided does not contain acceptance criteria or a study proving the device meets specific performance metrics in the way your request describes (e.g., using a test set with ground truth established by experts, MRMC studies, or standalone algorithm performance).
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (EkoSonic Endovascular Device with CU4.0) through a comparison of technological characteristics and performance testing against internal specifications and external standards (like ISO and IEC).
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance (in the context of clinical efficacy or diagnostic accuracy, as implied by "device performance" in your prompt). The table provided in the document (Table 1) lists "Product Specification" and "Purpose" with "Pass" results, which are more akin to design verification tests rather than clinical performance metrics.
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth
- Adjudication method
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
The device described is an "Embolectomy Catheter" used for ultrasound-facilitated infusion of fluids (including thrombolytics) for the treatment of pulmonary embolism and in peripheral vasculature. It is a physical medical device, not a diagnostic algorithm or AI system that would typically require the detailed clinical validation studies you're asking about.
What the document does provide regarding performance:
The document includes a "Performance Data" section (Section VII) which states: "Testing has confirmed that the EKOS PE Endovascular Device functions as intended and is substantially equivalent to the predicate device."
It then presents Table 1: Testing Overview Supporting the EKOS PE Endovascular System. This table lists various engineering and safety-related tests, their purpose, and the outcome ("Pass" for both initial and accelerated aged conditions). These are verification and validation tests to ensure the device meets its design specifications and complies with relevant standards.
Table 1: Testing Overview Supporting the EKOS PE Endovascular System (from the document)
| Product Specification | Purpose | EKOS PE Endovascular Device (Subject Device) T = 0 | Accelerated Aged (T=3 Years) |
|---|---|---|---|
| Physical Dimensions | Verified dimensional compatibility and stability with the MSD and DDC. | Pass | Pass |
| Tip Shape | Verified tip conformity to ISO 10555-1 requirements. | Pass | Pass |
| Kink Resistance | Verified device can be used within the target vasculature. | Pass | Pass |
| Tensile Strength | Verified device conformity to ISO 10555-1 requirements. | Pass | Pass |
| Electrical Safety | Verified device conformity IEC 60601-1 and IEC 60601-1-2 requirements. | Pass | Pass |
| Acoustic Characteristics | Verified device met specified acoustic design requirements. | Pass | Pass |
| Radiopacity | Verified device can be viewed under standard imaging techniques. | Pass | Pass |
| Pressure Resistance | Verified device lumens conformity to ISO 10555-1. | Pass | Pass |
| Temperature Sensing | Verified the device temperature sensors met specified design and functional requirements. | Pass | Pass |
| Functional Life | Verified device met specified functional life requirements. | Pass | Pass |
| Biocompatibility | Verified the device met biocompatibility requirements per ISO 10993-1. | Pass | Pass |
| Sterilization | Verified the device met sterilization requirements per ISO 11135. | Pass | Pass |
| Shelf Life | Verified the device met functional requirements after a 3-year shelf life. | N/A. | Pass |
| System Integration with CU4.0 | Verified the device integrates with the control unit, specifically, its acoustic protocol and enabled temperature safety features. | Pass | N/A. |
The "acceptance criteria" here are generally that the device "Passed" these various engineering and safety tests, demonstrating it functions as intended and is safe for its intended use, aligning with the standards and the predicate device's characteristics. There's no further detail on the methodology of these "Pass" assessments (e.g., specific quantitative thresholds beyond meeting standard requirements).
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August 17, 2020
EKOS Corporation Mr. Joshua Kim Sr. Regulatory Affairs Specialist 11911 North Creek Parkway S Bothell, Washington 98011
Re: K200648
Trade/Device Name: EKOS PE Endovascular Device with Control System 4.0 Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: QEY, KRA Dated: July 17, 2020 Received: July 20, 2020
Dear Mr. Kim:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200648
Device Name
EKOS PE Endovascular Device with Control Unit 4.0
Indications for Use (Describe)
The EKOS PE Endovascular Device with CU 4.0 is indicated for the:
- · Ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism.
- · Infusion of solutions into the pulmonary arteries.
- · Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Premarket Notification 510(k) Summary for K200648
l. Submitter
EKOS Corporation 11911 North Creek Parkway South Bothell, WA 98011
Phone: 425-415-3114 Fax: 425-415-3105
Contact Person: Joshua Kim Date Prepared: August 17, 2020
ll. Device
| Proprietary Name: | EKOS™ PE Endovascular Device with CU4.0 | EKOS PE Endovascular Devicewith CU4.0(Subject Device) | EkoSonic Endovascular Devicewith CU4.0(Predicate Device) | |
|---|---|---|---|---|
| Common or Usual Name: | Continuous Flush Catheter | 510(k) Number | K200648 | K183361 |
| Primary Classification Name: | Mechanical Thrombolysis Catheter (21 CFR §870.5150) | Product Code | QEY, KRA | KRA |
| Primary Product Code: | QEY | Indications forUse | The EKOS PE EndovascularSystem [with CU4.0] is indicatedfor the:• Ultrasound facilitated,controlled and selectiveinfusion of physician-specifiedfluids, includingthrombolytics, into thevasculature for the treatmentof pulmonary embolism.• Infusion of solutions into thepulmonary arteries.• Controlled and selectiveinfusion of physician-specifiedfluids, includingthrombolytics, into theperipheral vasculature. | The EkoSonic EndovascularDevice with CU4.0 is indicatedfor the:• Ultrasound facilitated,controlled and selectiveinfusion of physician-specifiedfluids, including thrombolytics,into the vasculature for thetreatment of pulmonaryembolism.• Infusion of solutions into thepulmonary arteries.• Controlled and selectiveinfusion of physician-specifiedfluids, including thrombolytics,into the peripheralvasculature. |
| FDA Panel/Device Class: | Cardiovascular; Class II | Principle ofOperation | The EKOS PE EndovascularSystem [EKOS PE EndovascularDevice with CU4.0] employsultrasound to facilitate thedelivery of thrombolytic agentsinto vascular blood clots. | The EkoSonic EndovascularSystem employs ultrasound tofacilitate the delivery ofthrombolytic agents intovascular blood clots. |
| Secondary Classification Name: | Catheter, Continuous Flush (21 CFR §870.1210) | Infusion HolePattern | Multiple side-holes | Multiple side-holes |
| Secondary Product Code: | KRA | CatheterWorking Length | 106 cm or 135 cm | 106 cm or 135 cm |
| FDA Panel/Device Class: | Cardiovascular; Class II | TreatmentZone Length | 8 cm - 20 cm | 6 cm - 50 cm |
lll. Predicate Devices
The EKOS PE Endovascular Device with CU4.0 is substantially equivalent to another legally marketed device. This predicate device is the EkoSonic Endovascular Device with CU4.0 (K183361).
No reference devices were used in this notification.
IV. Device Description
The EKOS PE Endovascular System consists of an EKOS PE Endovascular Device and CU4.0 (Control Unit 4.0 and Connector Interface Cables). The EKOS PE Endovascular Device consists of a single-use, disposable infusion catheter with removable ultrasound core. The infusion catheter contains multiple side holes distributed over the length of the treatment zone. The ultrasound core contains up to 20 ultrasound elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor catheter temperature. The Control System generates and controls the delivery of radiofrequency energy to the ultrasound core while monitoring and controlling the temperature of the treatment zone.
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V. Intended Use/Indications for use
The EKOS PE Endovascular System is indicated for the:
- Ultrasound facilitated, controlled and selective infusion of physician-specified fluids, . including thrombolytics, into the vasculature for the treatment of pulmonary embolism.
- . Infusion of solutions into the pulmonary arteries.
- . Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
VI. Comparison of Technological Characteristics with the Predicate Device
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E K.O)S)
| EKOS PE Endovascular Devicewith CU4.0(Subject Device) | EkoSonic Endovascular Devicewith CU4.0(Predicate Device) | |
|---|---|---|
| CompatibleGuide Wire | 0.035" | 0.035" |
| Outer Diameter | 7.7 Fr | 5.4 Fr |
| PlacementMode | Percutaneous/endovascular | Percutaneous/endovascular |
| PackagedSterile | Yes - EKOS PE EndovascularDevice | Yes - EkoSonic EndovascularDevice |
| Single-UseDisposable | Yes - EKOS PE EndovascularDevice | Yes - EkoSonic EndovascularDevice |
| MaterialsBiocompatible | Yes – EKOS PE EndovascularDevice | Yes - EkoSonic EndovsacularDevice |
| RadiopaqueMarkers | Yes on IDDCMSD ultrasound elements areradiopaque | Yes on IDDCMSD ultrasound elements areradiopaque |
| Mechanism ofAction | Ultrasound | Ultrasound |
| Energy Source | R/F electrical from CU convertedto ultrasound | R/F electrical from CU convertedto ultrasound |
| UltrasoundTransducer(s)in Catheter | 8 to 20 | 6 to 30 |
| AcousticCharacteristics | Frequency = 1.58-2.00 MHz | Frequency = 2.05 - 2.35 MHz |
| MaximumOutput PowerLimit | Power is available for ~100WPulses. The power output islimited by software to ~50W. | Power is available for ~100WPulses. The power output islimited by software to ~50W. |
| MaximumEkoSonicDeviceTemperature | Temperature monitoring,feedback and control systemlimits the surface temperature ofthe IDDC to 43°C duringoperation | Temperature monitoring,feedback and control systemlimits the surface temperature ofthe IDDC to 43°C duringoperation |
The device modifications described in the notification do not affect the intended use, indications for use, or the technological characteristics for the EKOS PE Endovascular System (EKOS PE Endovascular Device with CU4.0).
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VII. Performance Data
Testing has confirmed that the EKOS PE Endovascular Device functions as intended and is substantially equivalent to the predicate device.
| ProductSpecification | Purpose | EKOS PE Endovascular Device(Subject Device) | |
|---|---|---|---|
| T = 0 | Accelerated Aged(T=3 Years) | ||
| PhysicalDimensions | Verified dimensional compatibility and stabilitywith the MSD and DDC. | Pass | Pass |
| Tip Shape | Verified tip conformity to ISO 10555-1requirements. | Pass | Pass |
| Kink Resistance | Verified device can be used within the targetvasculature. | Pass | Pass |
| Tensile Strength | Verified device conformity to ISO 10555-1requirements. | Pass | Pass |
| Electrical Safety | Verified device conformity IEC 60601-1 and IEC60601-1-2 requirements. | Pass | Pass |
| AcousticCharacteristics | Verified device met specified acoustic designrequirements. | Pass | Pass |
| Radiopacity | Verified device can be viewed under standardimaging techniques. | Pass | Pass |
| PressureResistance | Verified device lumens conformity to ISO 10555-1. | Pass | Pass |
| TemperatureSensing | Verified the device temperature sensors metspecified design and functional requirements. | Pass | Pass |
| Functional Life | Verified device met specified functional liferequirements. | Pass | Pass |
| Biocompatibility | Verified the device met biocompatibilityrequirements per ISO 10993-1. | Pass | Pass |
| Sterilization | Verified the device met sterilizationrequirements per ISO 11135. | Pass | Pass |
| Shelf Life | Verified the device met functional requirementsafter a 3-year shelf life. | N/A. | Pass |
| SystemIntegration withCU4.0 | Verified the device integrates with the controlunit, specifically, its acoustic protocol andenabled temperature safety features | Pass | N/A. |
Table 1: Testing Overview Supporting the EKOS PE Endovascular System
Performance standards have not been promulgated for Mechanical Thrombolysis or Continuous Flush Catheters.
VIII. Conclusions
The EKOS PE Endovascular Device with CU4.0 is substantially equivalent to the predicate devices. The modifications to the EkoSonic Endovascular Device with CU4.0 do not affect the intended use or the technological characteristics for the system.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).